College of American Pathologists
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January 17, 2013  •  Volume 29, Number 2
Next Issue: Janurary 31, 2013
© 2013 College of American Pathologists

In This Issue:

CMS Announces Over 100 New ACOs Launched Jan. 1

CMS announced on Jan. 10 that 106 new accountable care organizations (ACOs) began operating on Jan. 1 as part of the agency’s Shared Savings Program. This total includes 15 Advanced Payment Model ACOs.

CAP ACO Resource Center

The CAP ACO Resource Center features recent news and resources on pathologists’ important role in coordinated care models.

This latest launch nearly doubles the size of this CMS program, bringing the total ACOs now operating to 250. The program began last April with 27 ACOs; 89 were added in July. An estimated 4 million Medicare fee-for-service beneficiaries are now assigned to an ACO, according to CMS’s Acting Principal Deputy Administrator Jonathan Blum, during a press event announcing the ACOs.

Blum added that there were over 150 applicants for the ACO program. The primary reason for rejection was an applicant’s inability to meet the 5,000 beneficiary threshold as outlined in the health care reform law.

The next application period for organizations that wish to participate in the Shared Savings Program beginning in January 2014 is summer 2013. More information is available on the CMS website.

CAP Maintains Gene Patent Opposition at Meeting with PTO

Gene patents pose a serious threat to medical advancement and patient care, explained CAP member Debra Leonard, MD, PhD, FCAP, at a Jan. 10 Roundtable on Genetic Diagnostic Testing hosted by the United States Patent and Trademark Office (USPTO). The College, which has long opposed gene patents, was joined by representatives from other health care provider and patient advocacy groups discussing gene patents, the legality of which will soon be taken up by the Supreme Court. The USPTO held the roundtable to gather information on how patents impact independent second opinion genetic diagnostic testing. The office is preparing a report on this issue for Congress in accordance with H.R. 1249, the America Invents Act.

The College believes that a gene patent inhibits innovation and broad availability of testing, explained Dr. Leonard, who spoke on behalf of the College, at the event. “As a consequence, patient access to care is limited to one or a few laboratories, the quality of patient care is jeopardized by limiting inter-laboratory proficiency testing comparisons, broad clinical observations correlating test results with disease characteristics are compromised and limit new discoveries, and training of health care providers across the United States is restricted,” she added.

In early December, the Supreme Court granted a writ of certiorari, to the ACLU, who petitioned on behalf of appellants in the Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al. lawsuit. This means that the Court will issue the final decision on the legality of gene patents as a result of its review of the Federal Appeals Court’s 2–1 ruling upholding patents on two human genes (BRCA1 & BRCA2) associated with hereditary breast and ovarian cancer Oral arguments are expected to begin in early April, with a decision expected by June 2013.

CAP’s Stage 3 Meaningful Use Comments Focus on Compliance Challenges

Pathologists continue to have difficulty meeting federal electronic health record (EHR) requirements designed for office-based physicians, noted the College in comments submitted on Jan. 14 to the HHS Office of the National IT Coordinator (ONC) HIT Policy Committee on the Committee’s recommendations for the potential Stage 3 requirements of the federal Meaningful Use IT program. ONC and CMS give special deference to the committee’s recommendations in drafting the Meaningful Use program’s rules.

The College also continues to urge permanent relief from penalties for pathologists in the program, as well as raise concerns on key recommendations such as how “abnormal” laboratory results might be automatically flagged for further action in the EHR.

CAP’s comments also suggest that potential future stages of Meaningful Use be reconsidered given the strain on the health care system of additional requirements. These include the demand of financial investment in IT infrastructure. “Most eligible providers (EPs) and hospitals will need to rely on data that pathologists and their laboratories generate,” the comments state. “The proposed Stage 3 recommendations only further this reliance. However, Meaningful Use incentive payments do not cover interface requirements for labs and represent substantial costs and barriers to interoperability to many individual laboratories that provide testing to multiple practice settings and diverse EHRs.”

CMS issued the final rules on Stage 1 in July 2010 and on Stage 2 in August 2012. The ONC is expected to release a proposed Stage 3 later this year, which is expected to accelerate the transition from a setting-specific focus to a collaborative, patient and family-centric approach.

NCSP, CAP Prevail with North Carolina Legislative Committee

Committee Report Cites CAP Standards for Regulating Release of Pathological Materials to Patient

Advocacy from both the North Carolina Society of Pathologists (NCSP) and the CAP prompted an Ad Hoc Committee of the North Carolina Legislature on January 4, 2013 to issue a report recommending against a new law regulating the release of pathological materials to patients. Instead, the committee report recommended new regulations that comply with the CAP’s professional standards.

The NCSP, with the support of the College, had opposed legislation requiring health organizations to provide all pathological materials collected from the patient to the patient, upon written request. In a May 2011 letter to members of the North Carolina state Senate and House of Representatives, NCSP President Kevin S. Smith, MD, FCAP, cited several problems with H.B. 795, Patient Access to Pathological Material. These included public health concerns regarding the release of pathological material and the likely impairment of patient diagnosis. In addition, the letter noted the potential conflict between the legislation and state and federal laws, including requirements for specimen retention under CLIA and accreditation standards.

The report recommends that the state medical board and division of health draft regulations regarding patient access to this material that is consistent with CAP and North Carolina Hospital Association Standards.

CAP Presents LDT Oversight Proposal to Cancer Leadership Council

While ongoing budget constraints threaten to delay the Food and Drug Administration’s (FDA) plans to increase oversight of laboratory developed tests (LDTs), interest in LDTs remains high among cancer patient advocacy groups. This week, former CAP Governor Gail H. Vance, MD, FCAP led a discussion with the Cancer Leadership Council (CLC), a patient-focused coalition of the nation’s top cancer advocacy organizations, on CAP’s proposal to involve FDA, CMS and a third party accreditor in overseeing the safety of LDTs.

The CLC’s members include the American Cancer Society, Susan G. Komen for the Cure Advocacy Alliance, National Breast Cancer Coalition, and the Ovarian Cancer National Alliance, among others including CAP. (See the complete list of CLC Participants.)

The diverse coalition focuses largely on public policy initiatives that guarantee cancer survivors access to high quality care. Dr. Vance was invited to present CAP’s LDT oversight proposal since so many of the tests associated with cancer detection, prognosis and treatment are LDTs.

The group had questions about the quality of the tests and the labs that produce them, Vance said. “Many variables factor into how well a test performs, which is why it is important for the pathologist and the clinician to work together and have a dialogue about test selection and interpreting results.”

“In addition to being dependable for differentiating different kinds of cancers and countless other diagnoses, LDTs allow laboratories to bring innovation to lab testing and to the clinical use of the data they provide,” Vance said. “The CAP oversight model ensures the tests are done reliably and consistently, without overly burdensome requirements that will stifle innovation and potentially impede patient access to care.”

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